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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Operative Dental
510(k) Number K043496
Device Name SPACELINE EMCIA, MODEL CU580
Applicant
J. Morita USA, Inc.
1425 K St., NW, Suite 1100
Washington,  DC  20005
Applicant Contact KEITH A BARRITT
Correspondent
J. Morita USA, Inc.
1425 K St., NW, Suite 1100
Washington,  DC  20005
Correspondent Contact KEITH A BARRITT
Regulation Number872.6640
Classification Product Code
EIA  
Date Received12/17/2004
Decision Date 02/16/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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